Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in GAD-7 Anxiety Scores
研究概览
简要总结
The goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias).
The main questions it aims to answer are:
- Does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions?
- What are parents' perspectives on group-based writing interventions for future support programs?
Participants will:
- Complete a short anxiety questionnaire (the General Anxiety Disorder-7 scale) at the beginning of the study
- Receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition
- Complete 5 journal entries over several weeks, writing about their experiences and feelings
- Complete the same anxiety questionnaire again after finishing the journal entries
- Participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (such as differences of sex development or hypospadias)
- •Able to read and understand English
- •Willing to complete a guided journaling intervention (through writing or dictation) over a period of approximately 5 weeks
- •Willing to participate in a 45 minute follow-up interview
- •Able to provide informed consent
排除标准
- •Parent/guardian with severe psychiatric disorder that would interfere with participation as determined by referring physician
- •Parent/guardian unable to complete either written journaling activities or dictation
- •Inability to provide informed consent
研究组 & 干预措施
Narrative Medicine Journaling Intervention
All participants in this single-arm pilot study will complete baseline GAD-7 anxiety assessments, participate in a guided journaling program, complete follow-up GAD-7 assessments, and take part in a qualitative interview. Parents of children with urogenital conditions (differences of sex development and hypospadias) will receive the narrative medicine intervention over a period of several weeks, with pre- and post-intervention anxiety measurements and interview assessments.
干预措施: Narrative Medicine Journaling Intervention (Behavioral)
结局指标
主要结局
Change in GAD-7 Anxiety Scores
时间窗: Change from baseline (pre-intervention) to approximately 6 weeks post-intervention initiation
Change from baseline in General Anxiety Disorder-7 (GAD-7) scores. The GAD-7 is a validated 7-item self-report questionnaire used to assess anxiety symptom severity. Scores range from 0-21, with higher scores indicating greater anxiety symptoms.
次要结局
- Qualitative Assessment of Anxiety Related to Child's Diagnosis(Measured at one follow-up interview, approximately 6 weeks after intervention initiation)
- Changes in Parental Coping Strategies(Measured at one follow-up interview, approximately 6 weeks after intervention initiation)
- Interest in Group-Based Writing Interventions(Approximately 6 weeks after intervention initiation)
- Feasibility and Acceptability of Journaling Intervention(Approximately 6 weeks after intervention initiation)
研究者
Sarah Schlegel
Attending Physician in Endocrinology, Instructor of Pediatrics
Boston Children's Hospital